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1.
Disabil Health J ; : 101645, 2024 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-38879412

RESUMO

BACKGROUND: More than seven million people with intellectual and/or developmental disabilities (ID/DD) live in the US and may face an elevated risk for COVID-19. OBJECTIVE: To identify correlates of COVID-19 and related hospitalizations among people with ID/DD in group homes in Massachusetts. METHODS: We collected data during March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2) from the Massachusetts Department of Public Health and six organizations administering 206 group homes for 1035 residents with ID/DD. The main outcomes were COVID-19 infections and related hospitalizations. We fit multilevel Cox proportional hazards models to estimate associations with observed predictors and assess contextual home- and organizational-level effects. RESULTS: Compared with Massachusetts residents, group home residents had a higher age-adjusted rate of COVID-19 in wave 1 (incidence rate ratio [IRR], 12.06; 95 % confidence interval [CI], 10.51-13.84) and wave 2 (IRR, 2.47; 95 % CI, 2.12-2.88) and a higher age-adjusted rate of COVID-19 hospitalizations in wave 1 (IRR, 17.64; 95 % CI, 12.59-24.70) and wave 2 (IRR, 4.95; 95 % CI, 3.23-7.60). COVID-19 infections and hospitalizations were more likely among residents aged 65+ and in group homes with 6+ resident beds and recent infection among staff and residents. CONCLUSIONS: Aggressive efforts to decrease resident density, staff-to-resident ratios, and staff infections through efforts such as vaccination, in addition to ongoing access to personal protective equipment and COVID-19 testing, may reduce COVID-19 and related hospitalizations in people with ID/DD living in group homes.

2.
Adm Policy Ment Health ; 51(1): 60-68, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37938475

RESUMO

This study examined COVID-19 infection and hospitalizations among people with serious mental illness who resided in residential care group homes in Massachusetts during the first year of the COVID-19 pandemic. The authors analyzed data on 2261 group home residents and COVID-19 data from the Massachusetts Department of Public Health. Outcomes included positive COVID-19 tests and COVID-19 hospitalizations March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2). Associations between hazard of outcomes and resident and group home characteristics were estimated using multi-level Cox frailty models including home- and city-level frailties. Between March 2020 and March 2021, 182 (8%) residents tested positive for COVID-19, and 51 (2%) had a COVID-19 hospitalization. Compared with the Massachusetts population, group home residents had age-adjusted rate ratios of 3.0 (4.86 vs. 1.60 per 100) for COVID infection and 13.5 (1.99 vs. 0.15 per 100) for COVID hospitalizations during wave 1; during wave 2, the rate ratios were 0.5 (4.55 vs. 8.48 per 100) and 1.7 (0.69 vs. 0.40 per 100). In Cox models, residents in homes with more beds, higher staff-to-resident ratios, recent infections among staff and other residents, and in cities with high community transmission risk had greater hazard of COVID-19 infection. Policies and interventions that target group home-specific risks are needed to mitigate adverse communicable disease outcomes in this population.Clinical Trial Registration Number This study provides baseline (i.e., pre-randomization) data from a clinical trial study NCT04726371.


Assuntos
COVID-19 , Transtornos Mentais , Humanos , COVID-19/epidemiologia , Lares para Grupos , Massachusetts/epidemiologia , Transtornos Mentais/epidemiologia , Casas de Saúde , Pandemias , Ensaios Clínicos como Assunto
3.
JAMA Health Forum ; 4(4): e230445, 2023 04 07.
Artigo em Inglês | MEDLINE | ID: mdl-37027164

RESUMO

Importance: Direct reports of the experiences of staff working in group homes for people with serious mental illness (SMI) and/or intellectual or developmental disabilities (ID/DD) are rarely reported. Hearing from workers about their experiences in the COVID-19 pandemic may inform future workforce and public policy. Objective: To gather baseline data on worker experience with the perceived effects of COVID-19 on health and work in the pandemic prior to initiating an intervention to mitigate the spread of COVID-19 and to measure differences in worker experience by gender, race, ethnicity, education, and resident population served (persons with SMI and/or IDD/DD). Design, Setting, and Participants: This mixed-mode, cross-sectional survey study was conducted using online then paper-based self-administration from May to September 2021 at the end of the first year of the pandemic. Staff working in 415 group homes that provided care within 6 Massachusetts organizations serving adults aged 18 years or older with SMI and/or ID/DD were surveyed. The eligible survey population included a census of staff who were currently employed in participating group homes during the study period. A total of 1468 staff completed or partially completed surveys. The overall survey response rate was 44% (range by organization, 20% to 52%). Main Outcomes and Measures: Self-reported experiential outcomes were measured in work, health, and vaccine completion. Bivariate and multivariate analyses explore experiences by gender, race, ethnicity, education, trust in experts and employers, and population served. Results: The study population included 1468 group home staff (864 [58.9%] women; 818 [55.7%] non-Hispanic Black; 98 [6.7%] Hispanic or Latino). A total of 331 (22.5%) group home staff members reported very serious perceived effects on health; 438 (29.8%) reported very serious perceived effects on mental health; 471 (32.1%) reported very serious perceived effects on health of family and friends; and 414 reported very serious perceived effects (28.2%) on access to health services, with statistically significant differences observed by race and ethnicity. Vaccine acceptance was higher among persons with higher educational attainment and trust in scientific expertise and lower among persons who self-reported as Black or Hispanic/Latino. A total of 392 (26.7%) respondents reported needing support for health needs, and 290 (19.8%) respondents reported needing support for loneliness or isolation. Conclusions and Relevance: In this survey study, approximately one-third of group home workers reported serious personal health and access to health care barriers during the first year of the COVID-19 pandemic in Massachusetts. Addressing unmet health needs and access to health and mental health services, including inequities and disparities by race, ethnicity, and education, should benefit staff health and safety, as well as that of the individuals with disabilities who rely on them for support and care.


Assuntos
COVID-19 , Adulto , Humanos , Feminino , Masculino , COVID-19/epidemiologia , Pandemias , Lares para Grupos , Estudos Transversais , Massachusetts/epidemiologia
4.
Contemp Clin Trials ; 125: 107053, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36539061

RESUMO

BACKGROUND: People with serious mental illness (SMI) and intellectual disabilities and/or developmental disabilities (ID/DD) living in group homes (GHs) and residential staff are at higher risk for COVID-19 infection, hospitalization, and death compared with the general population. METHODS: We describe a hybrid type 1 effectiveness-implementation cluster randomized trial to assess evidence-based infection prevention practices to prevent COVID-19 for residents with SMI or ID/DD and the staff in GHs. The trial will use a cluster randomized design in 400 state-funded GHs in Massachusetts for adults with SMI or ID/DD to compare effectiveness and implementation of "Tailored Best Practices" (TBP) consisting of evidence-based COVID-19 infection prevention practices adapted for residents with SMI and ID/DD and GH staff; to "General Best Practices" (GBP), consisting of required standard of care reflecting state and federal standard general guidelines for COVID-19 prevention in GHs. External (i.e., community-based research staff) and internal (i.e., GH staff leadership) personnel will facilitate implementation of TBP. The primary effectiveness outcome is incident SARS-CoV-2 infection and secondary effectiveness outcomes include COVID-19-related hospitalizations and mortality in GHs. The primary implementation outcomes are fidelity to TBP and rates of COVID-19 vaccination. Secondary implementation outcomes are adoption, adaptation, reach, and maintenance. Outcomes will be assessed at baseline, 3-, 6-, 9-, 12-, and 15-months post-randomization. CONCLUSIONS: This study will advance knowledge on comparative effectiveness and implementation of two different strategies to prevent COVID-19-related infection, morbidity, and mortality and promote fidelity and adoption of these interventions in high-risk GHs for residents with SMI or ID/DD and staff. CLINICAL TRIAL REGISTRATION NUMBER: NCT04726371.


Assuntos
COVID-19 , Adulto , Criança , Humanos , COVID-19/prevenção & controle , SARS-CoV-2 , Lares para Grupos , Vacinas contra COVID-19 , Deficiências do Desenvolvimento , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
J Clin Oncol ; 40(9): 978-987, 2022 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-34995128

RESUMO

PURPOSE: Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results. METHODS: Women presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments. RESULTS: Of 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio = 1.11; 90% CI, 0.82 to 1.52; P = .57). The median OS was 53.1 months (95% CI, 47.9 to not estimable) in the systemic therapy arm and 54.9 months (95% CI, 46.7 to not estimable) in the locoregional therapy arm. Locoregional progression was less frequent in those randomly assigned to locoregional therapy (3-year rate: 16.3% v 39.8%; P < .001). Quality-of-life measures were largely similar between arms. CONCLUSION: Early locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life.


Assuntos
Neoplasias da Mama , Neoplasias da Mama/tratamento farmacológico , Feminino , Humanos , Modelos de Riscos Proporcionais , Qualidade de Vida , Taxa de Sobrevida
6.
Am J Health Syst Pharm ; 79(4): 268-275, 2022 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-34752608

RESUMO

PURPOSE: This article highlights one health system's response to the market influx of biosimilars with the establishment of a process for formulary review and selection of preferred agents and support for therapeutic interchanges. SUMMARY: Through assessment of available literature, insurance payor coverage, and manufacturer-anticipated approvals of biosimilars, a strategic stance was developed to guide biosimilar order preparation, review, adoption, and implementation. The electronic medical record (EMR) is prepared for biosimilar implementation at least 6 to 12 months ahead of anticipated formulary review. The review includes assessment of a class (reference product and available biosimilars) after at least 2 biosimilars become available. Key health-system departments and clinicians are enlisted to support review of clinical, safety, and economic implications. Implementation of a preferred product relies on standard education, formulary availability, and staff awareness to address any perceived patient safety concerns and gather provider support. The standard steps developed now apply to all future biosimilar reviews, adoption plans, and ongoing monitoring. Barriers evaluated include changes in payor coverage and challenges in preparation of the EMR for future biosimilars, meeting precertification team education needs, and providing operational support for pharmacy inventory. CONCLUSION: To date, use of 5 preferred biosimilar products has led to significant cost savings to the institution, and the process has been endorsed by providers. The institution's successes can be attributed to clear communication with stakeholders and the development of a deliberate process, led by a multidisciplinary leadership team, for managing formulary, safety, and operational barriers in a thoughtful and systematic manner.


Assuntos
Medicamentos Biossimilares , Assistência Farmacêutica , Farmácias , Farmácia , Medicamentos Biossimilares/uso terapêutico , Redução de Custos , Humanos
7.
Clin Cancer Res ; 27(12): 3329-3338, 2021 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-33820779

RESUMO

PURPOSE: This open-label, multicenter, phase IB/II study evaluated sapanisertib, a dual inhibitor of mTOR kinase complexes 1/2, plus exemestane or fulvestrant in postmenopausal women with hormone receptor-positive (HR+)/HER2-negative (HER2-) advanced/metastatic breast cancer. PATIENTS AND METHODS: Eligible patients had previously progressed on everolimus with exemestane/fulvestrant and received ≤3 (phase IB) or ≤1 (phase II) prior chemotherapy regimens. Patients received sapanisertib 3 to 5 mg every day (phase IB), or 4 mg every day (phase II) with exemestane 25 mg every day or fulvestrant 500 mg monthly in 28-day cycles. Phase II enrolled parallel cohorts based on prior response to everolimus. The primary objective of phase II was to evaluate antitumor activity by clinical benefit rate at 16 weeks (CBR-16). RESULTS: Overall, 118 patients enrolled in phase IB (n = 24) and II (n = 94). Five patients in phase IB experienced dose-limiting toxicities, at sapanisertib doses of 5 mg every day (n = 4) and 4 mg every day (n = 1); sapanisertib 4 mg every day was the MTD in combination with exemestane or fulvestrant. In phase II, in everolimus-sensitive versus everolimus-resistant cohorts, CBR-16 was 45% versus 23%, and overall response rate was 8% versus 2%, respectively. The most common adverse events were nausea (52%), fatigue (47%), diarrhea (37%), and hyperglycemia (33%); rash occurred in 17% of patients. Molecular analysis suggested positive association between AKT1 mutation status and best treatment response (complete + partial response; P = 0.0262). CONCLUSIONS: Sapanisertib plus exemestane or fulvestrant was well tolerated and exhibited clinical benefit in postmenopausal women with pretreated everolimus-sensitive or everolimus-resistant breast cancer.


Assuntos
Neoplasias da Mama , Androstadienos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Feminino , Fulvestranto , Humanos , Pirazóis , Pirimidinas , Receptor ErbB-2/genética , Receptor ErbB-2/uso terapêutico , Receptores de Estrogênio , Receptores de Progesterona
8.
Breast Cancer Res Treat ; 188(2): 449-458, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33909203

RESUMO

PURPOSE: To characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study. METHODS: In NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan-Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points. RESULTS: Of the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63-1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32-2.23]). CONCLUSION: In NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.


Assuntos
Neoplasias da Mama , Qualidade de Vida , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Capecitabina/efeitos adversos , Feminino , Humanos , Quinolinas , Receptor ErbB-2/genética
9.
NPJ Breast Cancer ; 7(1): 29, 2021 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-33753748

RESUMO

Patients with triple-negative breast cancer (TNBC) who have residual disease after neoadjuvant therapy have a high risk of recurrence. We tested the impact of DNA-damaging chemotherapy alone or with PARP inhibition in this high-risk population. Patients with TNBC or deleterious BRCA mutation (TNBC/BRCAmut) who had >2 cm of invasive disease in the breast or persistent lymph node (LN) involvement after neoadjuvant therapy were assigned 1:1 to cisplatin alone or with rucaparib. Germline mutations were identified with BROCA analysis. The primary endpoint was 2-year disease-free survival (DFS) with 80% power to detect an HR 0.5. From Feb 2010 to May 2013, 128 patients were enrolled. Median tumor size at surgery was 1.9 cm (0-11.5 cm) with 1 (0-38) involved LN; median Residual Cancer Burden (RCB) score was 2.6. Six patients had known deleterious BRCA1 or BRCA2 mutations at study entry, but BROCA identified deleterious mutations in 22% of patients with available samples. Toxicity was similar in both arms. Despite frequent dose reductions (21% of patients) and delays (43.8% of patients), 73% of patients completed planned cisplatin. Rucaparib exposure was limited with median concentration 275 (82-4694) ng/mL post-infusion on day 3. The addition of rucaparib to cisplatin did not increase 2-year DFS (54.2% cisplatin vs. 64.1% cisplatin + rucaparib; P = 0.29). In the high-risk post preoperative TNBC/BRCAmut setting, the addition of low-dose rucaparib did not improve 2-year DFS or increase the toxicity of cisplatin. Genetic testing was underutilized in this high-risk population.

11.
Patient Educ Couns ; 102(1): 77-84, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30150125

RESUMO

OBJECTIVE: To assess the feasibility of a team-based prognosis and treatment goal discussion for women living with advanced breast cancer. METHODS: Female patients diagnosed with advanced breast cancer (n = 25) participated in a mixed methods study that evaluated the feasibility and effects of a planned and structured prognosis discussion. Audio analysis of the intervention appointments was conducted to assess intervention feasibility. Patient self-reports of prognosis related beliefs and treatment preferences were compared across intervention and usual care groups. RESULTS: Most patients found the T-PAT appointment challenging but worthwhile. Intervention uptake by clinicians was good, but some fidelity disruptions were noted. T-PAT participants were more likely to hold realistic beliefs about disease curability after the appointment. CONCLUSION: Productive prognosis discussions can be delivered effectively by a practice-based clinical team within a semi-structured patient education appointment. It was perceived by patients with advanced breast cancer as both valuable and acceptable. T-PAT clinicians found the intervention easy to deliver. PRACTICE IMPLICATIONS: Regular implementation of T-PAT may help clinicians' build prognosis discussion communication skills. T-PAT documentation provides valuable information that can be used to tailor ongoing care.


Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/terapia , Comunicação em Saúde , Equipe de Assistência ao Paciente , Relações Profissional-Paciente , Planejamento Antecipado de Cuidados , Estudos de Viabilidade , Feminino , Objetivos , Humanos , Pessoa de Meia-Idade , Prognóstico
12.
J Natl Compr Canc Netw ; 16(10): 1216-1247, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30323092

RESUMO

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for common physical and psychosocial consequences of cancer and cancer treatment to help healthcare professionals who work with survivors of adult-onset cancer in the posttreatment period. This portion of the guidelines describes recommendations regarding the management of anthracycline-induced cardiotoxicity and lymphedema. In addition, recommendations regarding immunizations and the prevention of infections in cancer survivors are included.


Assuntos
Sobreviventes de Câncer , Oncologia/normas , Neoplasias/terapia , Sobrevivência , Antraciclinas/efeitos adversos , Antibióticos Antineoplásicos/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Infecções Bacterianas/imunologia , Infecções Bacterianas/prevenção & controle , Cardiotoxicidade/diagnóstico , Cardiotoxicidade/etiologia , Cardiotoxicidade/terapia , Humanos , Hospedeiro Imunocomprometido/efeitos dos fármacos , Hospedeiro Imunocomprometido/imunologia , Hospedeiro Imunocomprometido/efeitos da radiação , Linfedema/induzido quimicamente , Linfedema/diagnóstico , Linfedema/terapia , Programas de Rastreamento/métodos , Programas de Rastreamento/normas , Oncologia/métodos , Neoplasias/complicações , Neoplasias/imunologia , Neoplasias/psicologia , Medição de Risco/métodos , Medição de Risco/normas , Sociedades Médicas/normas , Estados Unidos , Vacinação/métodos , Vacinação/normas , Viroses/imunologia , Viroses/prevenção & controle
13.
Hum Pathol ; 80: 163-169, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29894722

RESUMO

The transcription factor SOX10 mediates the differentiation of neural crest-derived cells, and SOX10 by immunohistochemistry (IHC) is used primarily for the diagnosis of melanoma. SOX10 expression has been previously documented in benign breast myoepithelial cells. However there is limited literature on its expression in triple-negative breast carcinoma (TNBC). The aim was to study the clinical, pathologic and molecular profiles of SOX10+ tumors in TNBC. Tissue microarrays of TNBC were evaluated for SOX10 expression in 48 cases. SOX10 expression was correlated with clinical and pathologic features such as age, grade, and stage. Gene expression was analyzed on RNA extracted from formalin-fixed paraffin-embedded (FFPE) specimens with Affymetrix 2.0 HTA. Co-expression of SOX10 with androgen receptor (AR), WT1, gross cystic disease fluid protein-15 (GCDFP-15), mammaglobin, epidermal growth factor receptor (EGFR), CK5/6 and GATA transcription factor 3 (GATA3) were also assessed. The mean age was 59.38 (range, 28-90 years). Overall, 37.5% cases (18/48) were SOX10+. There was no association between SOX10 expression and age, grade or stage of patients; 6 of 10 (60%) cases of basal-like 1 (BL1), and 5 of 8 cases of unstable (UNS) molecular subtype were SOX10+. One of 5 basal-like-2 (BL2), 1 of 6 immunomodulatory (IM), 1 of 4 mesenchymal (M), 1 of 5 luminal androgen receptor (LAR) and 2 of 8 mesenchymal stem cell (MSL) showed lower frequencies of SOX10 expression. There was negative correlation between SOX10 and AR+ subtypes (P < .002). SOX10 was positively correlated with WT1 (P = .05). SOX10 did not show significant correlation with mammaglobin, GCDFP15, EGFR, CK5/6 and GATA3. SOX10 expression in the basal-like and unstable molecular subtypes supports the concept that these neoplasms show myoepithelial differentiation.


Assuntos
Crista Neural/patologia , Fatores de Transcrição SOXE/metabolismo , Neoplasias de Mama Triplo Negativas/patologia , Adulto , Idoso , Biomarcadores Tumorais/análise , Feminino , Fator de Transcrição GATA3/metabolismo , Humanos , Imuno-Histoquímica/métodos , Pessoa de Meia-Idade , Fatores de Transcrição SOXE/genética , Neoplasias de Mama Triplo Negativas/diagnóstico
15.
J Natl Compr Canc Netw ; 15(9): 1140-1163, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28874599

RESUMO

Many cancer survivors experience menopausal symptoms, including female survivors taking aromatase inhibitors or with a history of oophorectomy or chemotherapy, and male survivors who received or are receiving androgen-ablative therapies. Sexual dysfunction is also common in cancer survivors. Sexual dysfunction and menopause-related symptoms can increase distress and have a significant negative impact on quality of life. This portion of the NCCN Guidelines for Survivorship provide recommendations for screening, evaluation, and treatment of sexual dysfunction and menopausal symptoms to help healthcare professionals who work with survivors of adult-onset cancer in the posttreatment period.


Assuntos
Oncologia , Menopausa , Qualidade de Vida , Sobrevivência , Feminino , Humanos , Pessoa de Meia-Idade , Oncologia/normas , Menopausa/fisiologia , Qualidade de Vida/psicologia
16.
J Clin Oncol ; 35(10): 1061-1069, 2017 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-28045625

RESUMO

Purpose To determine the pathologic complete response (pCR) rate in estrogen receptor (ER) -positive primary breast cancer triaged to chemotherapy when the protein encoded by the MKI67 gene (Ki67) level was > 10% after 2 to 4 weeks of neoadjuvant aromatase inhibitor (AI) therapy. A second objective was to examine risk of relapse using the Ki67-based Preoperative Endocrine Prognostic Index (PEPI). Methods The American College of Surgeons Oncology Group (ACOSOG) Z1031A trial enrolled postmenopausal women with stage II or III ER-positive (Allred score, 6 to 8) breast cancer whose treatment was randomly assigned to neoadjuvant AI therapy with anastrozole, exemestane, or letrozole. For the trial ACOSOG Z1031B, the protocol was amended to include a tumor Ki67 determination after 2 to 4 weeks of AI. If the Ki67 was > 10%, patients were switched to neoadjuvant chemotherapy. A pCR rate of > 20% was the predefined efficacy threshold. In patients who completed neoadjuvant AI, stratified Cox modeling was used to assess whether time to recurrence differed by PEPI = 0 score (T1 or T2, N0, Ki67 < 2.7%, ER Allred > 2) versus PEPI > 0 disease. Results Only two of the 35 patients in ACOSOG Z1031B who were switched to neoadjuvant chemotherapy experienced a pCR (5.7%; 95% CI, 0.7% to 19.1%). After 5.5 years of median follow-up, four (3.7%) of the 109 patients with a PEPI = 0 score relapsed versus 49 (14.4%) of 341 of patients with PEPI > 0 (recurrence hazard ratio [PEPI = 0 v PEPI > 0], 0.27; P = .014; 95% CI, 0.092 to 0.764). Conclusion Chemotherapy efficacy was lower than expected in ER-positive tumors exhibiting AI-resistant proliferation. The optimal therapy for these patients should be further investigated. For patients with PEPI = 0 disease, the relapse risk over 5 years was only 3.6% without chemotherapy, supporting the study of adjuvant endocrine monotherapy in this group. These Ki67 and PEPI triage approaches are being definitively studied in the ALTERNATE trial (Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment in Postmenopausal Women: A Phase III Study; clinical trial information: NCT01953588).


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Inibidores da Aromatase/uso terapêutico , Neoplasias da Mama/química , Neoplasias da Mama/tratamento farmacológico , Antígeno Ki-67/análise , Recidiva Local de Neoplasia , Idoso , Anastrozol , Androstadienos/uso terapêutico , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Tomada de Decisão Clínica , Feminino , Seguimentos , Humanos , Antígeno Ki-67/genética , Letrozol , Pessoa de Meia-Idade , Índice Mitótico , Terapia Neoadjuvante/métodos , Metástase Neoplásica , Estadiamento de Neoplasias , Nitrilas/uso terapêutico , Valor Preditivo dos Testes , Prognóstico , Modelos de Riscos Proporcionais , Receptores de Estrogênio/análise , Receptores de Estrogênio/genética , Receptores de Progesterona/genética , Taxa de Sobrevida , Transcriptoma , Triazóis/uso terapêutico
17.
BMC Med Genomics ; 9(1): 71, 2016 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-27871291

RESUMO

BACKGROUND: Research suggests that multidisciplinary genomic tumor boards (MGTB) can inform cancer patient care, though little is known about factors influencing how MGTBs interpret genomic test results, make recommendations, and perceive the utility of this approach. This study's objective was to observe, describe, and assess the establishment of the Breast Multidisciplinary Genomic Tumor Board, the first MGTB focused on interpreting genomic test results for breast cancer patients with advanced disease. METHODS: We conducted a qualitative case study involving participant observation at monthly MGTB meetings from October 2013 through November 2014 and interviews with 12 MGTB members. We analyzed social dynamics and interactions within the MGTB regarding interpretation of genomic findings and participants' views on effectiveness of the MGTB in using genomics to inform patient care. RESULTS: Twenty-two physicians, physician-scientists, basic scientists, bioethicists, and allied care professionals comprised the MGTB. The MGTB reviewed FoundationOne™ results for 40 metastatic breast cancer patients. Based on findings, the board mostly recommended referring patients to clinical trials (34) and medical genetics (15), and Food and Drug Administration-approved (FDA) breast cancer therapies (13). Though multidisciplinary, recommendations were driven by medical oncologists. Interviewees described providing more precise care recommendations and professional development as advantages and the limited actionability of genomic test results as a challenge for the MGTB. CONCLUSIONS: Findings suggest both feasibility and desirability of pooling professional expertise in genomically-guided breast cancer care and challenges to institutionalizing a Breast MGTB, specifically in promoting interdisciplinary contributions and managing limited actionability of genomic test results for patients with advanced disease.


Assuntos
Neoplasias da Mama/genética , Genômica , Comunicação Interdisciplinar , Assistência ao Paciente/métodos , Neoplasias da Mama/patologia , Humanos
18.
J Investig Med ; 64(8): 1241-1245, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27466395

RESUMO

Sentinel lymph node biopsy (SLNB) is the standard of care for surgical evaluation of early-stage breast cancer and is being employed as a quality metric for accreditation of breast centers. Previous studies report disparities in SLNB receipt. The goal of this study is to determine SLNB rates and explore rationale for non-receipt of SLNB. Patients with early-stage breast cancer diagnosed between 2010 and 2011 were identified from the University Hospitals Case Medical Center tumor registry. Multivariable logistic models were used to identify clinical and demographic risk factors for patients who did not receive SLNB. We performed chart reviews to elucidate reasons for the lack of SLNB. Our total sample was 479 patients; of them 432 (90.2%) received SLNB. On average, patients who received SLNB were younger than those who did not receive SLNB (61 compared to 79 years, respectively). Patients ≥80 years were 96% less likely to receive SLNB compared to patients <65 years (OR 0.04; 95% CI 0.00 to 0.14). There were no differences in SLNB by race, between patients undergoing Medicare or Medicaid and managed care, by surgeon specialty, or across medical centers. Chart review determined that 45/47 patients did not have SLNB, because it was a clinical decision-making; advanced age (>80 years) was cited in 27/47 women. Older women had much lower odds of receiving SLNB; however, non-receipt of SLNB was often due to a clinical reasoning. Our study highlights the importance of clinical reasoning in receiving SLNB, whereas other studies solely employing administrative databases do not.


Assuntos
Neoplasias da Mama/etnologia , Neoplasias da Mama/epidemiologia , Grupos Raciais , Biópsia de Linfonodo Sentinela , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Análise Multivariada
19.
J Natl Compr Canc Netw ; 14(6): 715-24, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27283164

RESUMO

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for common consequences of cancer and cancer treatment. They are intended to aid health care professionals who work with survivors of adult-onset cancer in the posttreatment period, including those in general oncology, specialty cancer survivor clinics, and primary care practices. Guidance is also provided to help promote physical activity, weight management, and proper immunizations in survivors. This article summarizes the NCCN Survivorship panel's discussions for the 2016 update of the guidelines regarding the management of anxiety, depression, posttraumatic stress disorder-related symptoms, and emotional distress in survivors.


Assuntos
Neoplasias/mortalidade , Humanos , Neoplasias/terapia , Taxa de Sobrevida
20.
J Cancer Surviv ; 9(2): 223-9, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25297542

RESUMO

PURPOSE: Breast cancer survivorship care is provided by surgical and medical oncologists, primary care physicians (PCPs), and nurse practitioner survivorship specialists (NPs). The study objective was to identify whether frequency of cancer screening and discussion of healthy lifestyles differed across these provider types. We also determined differences by provider in survivor reported follow through with lifestyle recommendations. METHODS: Breast cancer survivors completed surveys regarding the type of health-care provider they most recently saw, cancer screening, discussion, and self-reported lifestyle change since their breast cancer diagnosis. RESULTS: Seven hundred fifty-nine breast cancer survivors (78.7 % of those invited) completed the survey; 51.8 % indicated that their last visit was with a medical oncologist. There was no difference in rates of cancer screening (colon, cervical, and breast) among types of providers. A significantly larger proportion of patients who last saw an NP reported that they had discussed physical activity (78.6 %) as compared to medical oncologist 54.4 %, surgeon 43.1 %, radiation oncologist 64.1 %, and PCP 61.3 % (p < 0.001). Similar observations were observed for discussion of nutrition and weight (NP 70.0 %, medical oncologist 36.5 %, surgeon 25.7 %, radiation oncologist 48.7 %, PCP 35.5 %; p < 0.001). There was no significant difference across provider type in self-reported implementation of change in physical activity or diet. CONCLUSIONS: Our data indicate that a visit to the NP was related to comparable screening rates, but despite that NPs are more often discussing lifestyle modification, self-reported change in nutrition and physical exercise did not differ across provider type. IMPLICATIONS FOR CANCER SURVIVORS: NPs perform favorably with respect to lifestyle recommendations. Given the reported lack of lifestyle change, it is important to triage to providers who specialize in lifestyle modification and, if plausible, learn and provide actual evidence-based approaches to achieve positive outcomes in this area.


Assuntos
Neoplasias da Mama/mortalidade , Detecção Precoce de Câncer , Segunda Neoplasia Primária/diagnóstico , Profissionais de Enfermagem , Médicos de Atenção Primária/estatística & dados numéricos , Comportamento de Redução do Risco , Sobreviventes , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Comportamental/educação , Terapia Comportamental/estatística & dados numéricos , Neoplasias da Mama/patologia , Neoplasias da Mama/reabilitação , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Segunda Neoplasia Primária/epidemiologia , Relações Enfermeiro-Paciente , Educação de Pacientes como Assunto/estatística & dados numéricos , Relações Médico-Paciente , Especialização/estatística & dados numéricos , Inquéritos e Questionários
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